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IRCT20150206020981N4 IRCT 2022-12-19 Sinacell Company Evaluation of safety and efficacy of focal intramuscular injection of wharton’s gelly-derived mesenchymal stem cell in Duchenne muscular dystrophy pediatrics between 5 to 12 years old Evaluation of safety and efficacy of focal intramuscular injection of wharton’s gelly-derived mesenchymal stem cell in Duchenne muscular dystrophy pediatrics between 5 to 12 years old 2022-12-19 anticipated 5 Complete https://irct.ir/trial/67403 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Duchenne muscular dystrophy. Intervention group: In each injection, 1million mesenchymal cell derived from Wharton's gelly is injected per kilogram of body weight. The injection volume of 25 cc includes a suspension containing one million mesenchymal cells, two local injections are performed in 4 to 5 areas under the muscle fascia at an interval of 45 days. Yes - There is a plan to make this available What will be shared: The only some part of data will be shared. When: 5 months after publish To whom: Only academic researcher Conditions: By official permission Where to obtain: By the corresponding author How to obtain: By the official request to the corresponding author, if she/he agrees to it. Comments:
public Khadijeh Hajinaghi Tehrani
Farhikhtegan Hospital,Tehran Province, Tehran, Hesarak, Shohadaye Hesarak Blvd
Tehran Iran (Islamic Republic of) 1477899679 +98 21 4486 7262 Khtehrani@iautmu.ac.ir Islamic Azad University scientific Khadijeh Hajinaghi Tehrani
Farhikhtegan Hospital,Tehran Province, Tehran, Hesarak, Shohadaye Hesarak Blvd
Tehran Iran (Islamic Republic of) 1477899679 +98 21 4486 7262 Khtehrani@iautmu.ac.ir Islamic Azad University Iran (Islamic Republic of) Age between 5 to 12 Genetic evidence of Duchenne disease as a cause of myopathy The patient's ability to walk is not completely lost and the use of assistive devices such as canes and walkers is not permanent. The patient's muscle strength is decreasing Willingness and satisfaction to participate in the study by the patient's legal guardian in decision making and willingness to participate regularly in follow-up courses Weight between 15 to 35 5 years 12 years Male Advanced motor impairment leading to permanent use of crutches, walkers and wheelchairs A history of known malignancy History of associated genetic and non-genetic degenerative diseases A history of any other acute or chronic illness that, at the discretion of the clinician responsible for implementing the plan, prevents the patient from entering the study. G71.0 Muscular dystrophy Treatment - Drugs Intervention group: In each injection, 1million mesenchymal cell derived from Wharton's gelly is injected per kilogram of body weight. The injection volume of 25 cc includes a suspension containing one million mesenchymal cells, two local injections are performed in 4 to 5 areas under the muscle fascia at an interval of 45 days Respiratory Function. Timepoint: 1, 3, 6, 9 and 12 month after injection. Method of measurement: Spirometery. Muscular Force. Timepoint: First every 14 days to 1 month, then Every 1 month to 1 year. Method of measurement: Physical Exam. Cardiac Function. Timepoint: 1, 3, 6, 9 and 12 month after injection. Method of measurement: Echocardiography. Muscular Enzymes. Timepoint: 1, 3, 6, 9 and 12 month after injection. Method of measurement: Lab Data. Sinacell Company Approved 2022-12-04 Ethics Committee on Research Islamic Azad University Pharmaceutical Sciences Branch Tehran Province, Tehran, District 1، Yakhchal Street، Yasaman Alley Tehran Tehran Iran (Islamic Republic of)